First-in-human study of JNJ-67571244, a CD33 × CD3 bispecific antibody, in relapsed/refractory acute myeloid leukemia and myelodysplastic syndrome.

Relapsed/refractory (r/r) acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS) outcomes remain poor. A targeted cluster of differentiation (CD)33 × CD3 bispecific antibody, JNJ-67571244, was assessed to identify the maximum tolerated dose (MTD), recommended phase II dose (RP2D), safety and tolerability, and preliminary clinical activity in patients with r/rAML or r/rMDS. This first-in-human, open-label, phase I, dose-escalation/dose-expansion study included patients with r/rAML or r/rMDS who were ineligible for or had exhausted standard therapeutic options. JNJ-67571244 was administered intravenously or subcutaneously using step-up dosing until ≥1 discontinuation condition was met. Outcomes included safety/tolerability, preliminary clinical activity, and systemic pharmacokinetics and pharmacodynamics. The study was terminated after evaluating 10 dose-escalation cohorts (n = 68) and before starting dose-expansion. Overall, 11 (16.2%) patients experienced ≥1 dose-limiting toxicity; all experienced ≥1 treatment-emergent adverse event (TEAE; treatment related: 60 [88.2%]); and 64 (94.1%) experienced ≥1 TEAE of Grade ≥3 toxicity (treatment related: 28 [41.2%]). Although some patients had temporary disease burden reductions, no responses were seen. JNJ-67571244 administration increased multiple cytokines, which coincided with incidence of cytokine release syndrome, infusion-related reactions, and elevated liver function tests. A prolonged step-up strategy was tested to improve tolerability, though this approach did not prevent hepatotoxicity. T-cell activation following treatment suggested target engagement but did not correlate with clinical activity. Safely reaching the projected exposure level for JNJ-67571244 efficacy was not achieved, thus MTD and RP2D were not determined.

Correlation of Impedance Cardiography-Derived and Cardiac Magnetic Resonance-Derived Stroke Volumes.

Cardiac output (CO) and other hemodynamic parameter measurements play an important role in the management of cardiovascular conditions; however, due to limitations of current day technologies, such measurements are either not routinely performed or incorporated into clinical practice. Moreover, measurement of these hemodynamic parameters in the outpatient setting at different time points to assess interval change is currently not feasible. We attempted to validate total-body impedance cardiography-based Non-Invasive Cardiac System (NICaS) derived stroke volume (SV) with that from cardiac magnetic resonance (CMR), a current day gold standard method of assessment. We compared SV, as it is the primary unit of measurement utilized by both technologies. Forty-one consecutive patients undergoing CMR were also investigated by NICaS following CMR. The consistency of non-invasive technology-derived SV measurement was validated by NICaS measurement in 10 subjects, both before and after CMR. Of the 41 enrolled patients; data from 38 patients was adequate for comparison (motion artifact prevented CMR measures in 3 patients). Fourteen patients (37%) were female; mean age was 55 ± 15 years (28-87 years) and body-mass index was 28.7 ± 5.5 kg/m2 (20.5-41.9 kg/m2). Hypertrophic cardiomyopathy (9/41) was the most common study indication for CMR. NICaS-derived SV strongly correlated with CMR [NICaS 77 ± 20 ml (31-123 ml) and CMR 84 ± 23 ml (47-132 ml); P < 0.001; r = 0.77; ICC = 0.73]. The Bland-Altman limits of agreement between NICaS and CMR were -26.7% and 39.9%. NICaS-derived SV collected before and after MRI did not differ [80 ± 18 ml (51-102 ml) pre and 76 ± 17 ml (50-99 ml) post; P = 0.0007, Kappa = 1]. Agreement between NICaS-derived and CMR-derived SV was within the acceptable range of boundaries set by the US Food and the Drug Administration. Consistency in SV measurement at different time-points may allow use of this technology to identify interval hemodynamic changes noninvasively.

ECMO During COVID-19: A Society of Thoracic Surgeons/Extracorporeal Life Support Organization Survey.

Background: The Society of Thoracic Surgeons Workforce on Critical Care and the Extracorporeal Life Support Organization sought to identify how the coronavirus disease 2019 (COVID-19) pandemic has changed the practice of venoarterial (VA) and venovenous (VV) extracorporeal membrane oxygenation (ECMO) programs across North America. Methods: A 26-question survey covering 6 categories (ECMO initiation, cannulation, management, anticoagulation, triage/protocols, and credentialing) was emailed to 276 North American Extracorporeal Life Support Organization centers. ECMO practices before and during the COVID-19 pandemic were compared. Results: Responses were received from 93 (34%) programs. The percentage of high-volume (>20 cases per year) VV ECMO programs increased during the pandemic from 29% to 41% (P < .001), as did institutions requiring multiple clinicians for determining initiation of ECMO (VV ECMO, 25% to 43% [P = .001]; VA ECMO, 20% to 32% [P = .012]). During the pandemic, more institutions developed their own protocols for resource allocation (23% before to 51%; P < .001), and more programs created sharing arrangements to triage patients and equipment with other centers (31% to 57%; P < .001). Direct thrombin inhibitor use increased for both VA ECMO (13% to 18%; P = .025) and VV ECMO (12% to 24%; P = .005). Although cardiothoracic surgeons remained the primary cannulating proceduralists, VV ECMO cannulations performed by pulmonary and critical care physicians increased (13% to 17%; P = .046). Conclusions: The Society of Thoracic Surgeons/Extracorporeal Life Support Organization collaborative survey indicated that the pandemic has affected ECMO practice. Further research on these ECMO strategies and lessons learned during the COVID-19 pandemic may be useful in future global situations.

Barriers to Successful Discharge After Cardiac Surgery: A Focus Group Study and Cross-Sectional Survey.

At present, there is a lack of information on patient and caregiver values, and perceived priorities and barriers, to guide successful post-discharge recovery. This was a single center, multiple methods study that investigated patient, caregiver, and health care provider perceptions of the discharge process after cardiac surgery. Themes emerging from focus group discussions with patients and caregivers were used to develop surveys relating to values, barriers, and challenges relating to the discharge process. Thirty-two patients (n = 16) and caregivers (n = 16) participated in four separate focus groups. Four themes emerged from these discussions: (1) a lack of understanding about what the discharge process entails and when discharge is appropriate, (2) issues relating to the information provided to patients at the time of discharge, (3) participant experiences with the health care system, and (4) the experiences of caregivers. Seventy-eight patients, 34 caregivers, 53 nurses and/or other allied health professionals, and 8 surgeons completed the cross-sectional surveys. The most important component of the discharge process for patients and caregivers was "knowing what to do in an emergency." Health care providers less accurately identified what caregivers perceived as the most important aspects of the discharge process.Statements relating to informational barriers to discharge were the most discordant among patient and caregiver respondents. After discharge, patients and caregivers identified the need for longer-term follow up with the surgeon and more support in the community. Incorporation of patient and caregiver values to guide the post-cardiac surgery discharge process is essential to promote successful recovery.

Long-term survival and quality of life after extracorporeal membrane oxygenation.

OBJECTIVES: Long-term data on patient survivors after extracorporeal membrane oxygenation (ECMO) support remains limited. This study sought to examine the 5-year survival and health-related quality of life (HRQoL) of patients treated with venoarterial (VA)- or venovenous (VV)-ECMO. METHODS: A single-center retrospective chart review and survival analysis was conducted on all patients who required ECMO from December 2007 to June 2019. Cross-sectional HRQoL assessments were performed using 8 standardized questionnaires among survivors. RESULTS: Records for 370 ECMO patients (288 VA-ECMO, 82 VV-ECMO) were reviewed. Survival at 5 years was 33% (VA-ECMO) and 36% (VV-ECMO). Among patients that survived to 30 days, 5-year survival rates were 73% (VA-ECMO) and 71% (VV-ECMO). Sixty surviving patients (56%) had HRQoL assessments (48 VA-ECMO, 12 VV-ECMO). Median follow-up time was 4.2 (VA-ECMO) and 5.7 years (VV-ECMO). Fourteen (29%) VA-ECMO patients and 9 (75%) VV-ECMO patients reported difficulty with any activity of daily living whereas 13 (27%) VA-ECMO patients and 8 (67%) VV-ECMO patients reported difficulty with any instrumental activity of daily living. Eleven (23%) VA-ECMO patients and 7 (58%) VV-ECMO patients reported a high post-traumatic stress disorder score. Low decision regret scores in both cohorts indicated minimal regret that ECMO was initiated. CONCLUSIONS: Five-year clinical and patient-centered outcomes of patients requiring ECMO support is acceptable in those who survived the initial 30 days. Among ECMO survivors, persistent HRQoL concerns were apparent, highlighting the importance of longer-term postdischarge follow-up.

Diagnostic accuracy of the "4 A's Test" delirium screening tool for the postoperative cardiac surgery ward.

BACKGROUND: Delirium is prevalent and underdetected among cardiac surgery patients on the postoperative ward. This study aimed to validate the 4 A's Test delirium screening tool and evaluate its accuracy both when used by research assistants and when subsequently implemented by nursing staff on the ward. METHODS: This single-center, prospective observational study evaluated the performance of the 4 A's Test administered by research assistants (phase 1) and nursing staff (phase 2). Assessments were undertaken during the patients' first 3 postoperative days on the postcardiac surgery ward along with previous routine nurse-led Confusion Assessment Method assessments. These index tests were compared with a reference standard diagnosis of delirium based on Diagnostic and Statistical Manual of Mental Disorders 5th Edition criteria. Surveys regarding delirium screening were administered to nurses pre- and postimplementation of the 4 A's Test in phase 2 of the study. RESULTS: In phase 1, a total of 137 patients were enrolled, of whom 24.8% experienced delirium on the postoperative cardiac ward. The 4 A's Test had a sensitivity of 85% (95% confidence interval, 73-93) and a specificity of 90% (95% confidence interval, 85-93) compared with the reference standard. The nurse-assessed Confusion Assessment Method had a sensitivity of 23% (95% confidence interval, 13-37) and specificity of 100% (95% confidence interval, 99-100). In phase 2, nurses (n = 51) screened 179 patients for delirium using the 4 A's Test. Compared with the reference rater, the 4 A's Test had a sensitivity of 58% (95% confidence interval, 28-85) and specificity of 94% (95% confidence interval, 85-98). Postimplementation, 64% of nurses thought that the 4 A's Test improved their confidence in delirium detection, and 76% of nurses would consider routine 4 A's Test use. CONCLUSIONS: The 4 A's Test demonstrated moderate sensitivity and high specificity to detect delirium in a real-world setting after cardiac surgery on the postoperative ward. A modified model of use with less frequent administration, along with increased engagement of the postoperative team, is recommended to improve early delirium detection on the cardiac surgery postoperative ward.

Validation of the Emory Risk Score in the Transcatheter Aortic Valve Implantation Population: A Canadian Perspective.

Background: Permanent pacemaker (PPM) implantation may be indicated post-transcatheter aortic valve implantation (TAVI). The Emory Risk Score (ERS) is a validated predictive risk score of the need for a PPM post-TAVI using a balloon-expandable valve. Our objectives were to determine the validity of the ERS in our local TAVI population with both balloon-expandable and self-expanding valves and to identify additional electrocardiographic (ECG) parameters predictive of the need for a PPM post-TAVI. Methods: Retrospective chart and electronic database reviews were performed to collect demographic and procedural information. Two expert readers reviewed all ECGs. Independent factors associated with PPM implantation were examined with multivariable logistic regression via a stepwise selection process with calculation of the area under the receiver operating characteristic curve to assess model discrimination. Results: The overall PPM implantation rate was 11.7%; rates were 9% for the Sapien 3 valves, 10% for the Evolut Pro valves, and 17% for the Evolut R valves. The ERS was found to not be predictive of need for PPM post-TAVI for the entire cohort. Right bundle branch block was the only ERS parameter independently associated with new PPM implant (8.5% vs 25%, odds ratio = 3.59, P = 0.01). No additional ECG parameters met the criteria for statistical significance. Conclusions: The poor predictive value of the ERS in determining the need for a PPM post-TAVI in our patient population suggests that further refinement of a formula (or risk-calculator) is warranted. Identification of a precise risk-calculator is likely to facilitate patient mobilization and reduce inpatient healthcare resource utilization.

Introduction: L'implantation d'un stimulateur cardiaque permanent (SCP) peut être indiquée après l'implantation valvulaire aortique par cathéter (post-IVAC). L'Emory Risk Score (ERS) est un score de prédiction du risque validé de la nécessité d'un SCP post-IVAC au moyen d'une valve expansible par ballonnet. Nous avions pour objectif de déterminer la validité de l'ERS auprès de notre population ayant eu une IVAC soit par valve expansible par ballonnet ou valve auto-expansible, et de déterminer d'autres paramètres électrocardiographiques (ECG) prédictifs de la nécessité d'un SCP post-IVAC. Méthodes: Nous avons réalisé des revues rétrospectives de dossiers et de bases de données électroniques pour collecter les données démographiques et interventionnelles. Deux experts ont lu et interprété tous les ECG. Les facteurs indépendants associés à l'implantation du SCP ont été examinés en effectuant la régression logistique multivariée par processus de sélection pas-à-pas au moyen du calcul de la surface sous la courbe caractéristique d'efficacité du récepteur afin d'évaluer la discrimination du modèle. Résultats: Le taux global d'implantation d'un SCP était de 11,7 % ; les taux étaient de 9 % pour les valves Sapien 3, de 10 % pour les valves Evolut Pro et de 17 % pour les valves Evolut R. Nous avons observé que l'ERS ne permettait pas de prédire si l'implantation d'un SCP post-IVAC était nécessaire pour la cohorte entière. Le bloc de branche droit était le seul paramètre de l'ERS indépendamment associé à la nouvelle implantation d'un SCP (8,5 % vs 25 %, rapport de cotes = 3,59, P = 0,01). Aucun autre paramètre ECG ne satisfaisait au critère de signification statistique. Conclusions: La faible valeur prédictive de l'ERS à déterminer la nécessité d'un SCP post-IVAC au sein de notre population de patients montre que des améliorations de la formule (ou calculateur de risques) sont justifiées. L'identification d'un calculateur de risques précis devrait favoriser l'adhésion des patients et réduire l'utilisation des ressources en soins de santé en milieu hospitalier.

Using the Zwolle Risk Score at Time of Coronary Angiography to Triage Patients With ST-Elevation Myocardial Infarction Following Primary Percutaneous Coronary Intervention or Thrombolysis.

Background The Zwolle Risk Score was designed to identify the risk of complications in patients with ST-segment‒elevation myocardial infarction (STEMI) following percutaneous coronary intervention (PCI). Its utility following PCI in STEMI treated with thrombolysis is unknown. The objective was to evaluate the safety of using the Zwolle Risk Score to triage patients with STEMI following PCI, including patients receiving thrombolysis. Methods and Results Patients aged ≥18 years with STEMI and primary PCI or PCI after thrombolysis were included. A triage protocol was developed, with high-risk patients those with Zwolle Risk Score ≥4 triaged to the cardiac intensive care unit. A prospective evaluation of the triaging protocol was performed on 452 patients, mean age 65±12 years, 73% men. Median Zwolle Risk Score was 3 (interquartile range, 2‒5), with 257 low-risk (57%), and 195 high-risk (43%) patients. Adherence to the protocol was 91%. In-hospital mortality was 0.4% in low-risk and 13% in high-risk patients (P<0.001). Seventy-two patients (16%) received thrombolysis. Median time post-thrombolysis to PCI was 281 minutes (interquartile range, 219‒376). In-hospital mortality was 0% versus 9% (P=0.083) for low- and high-risk patients, respectively. High-risk patients had higher rates of cardiogenic shock (34% versus 1%, P<0.001), pulmonary edema (60% versus 9%, P<0.001), arrhythmia (25% versus 2%, P<0.001), blood transfusion (10% versus 2%, P<0.001), and stroke (4% versus 0.4%, P=0.011). Median hospital costs decreased by $1419 per low-risk patient after protocol implementation. Conclusions For patients with STEMI following primary PCI or PCI following thrombolysis, a Zwolle-based triaging system is safe and may decrease cardiac intensive care unit usage costs.

Does a Heart Team Improve Clinical Outcomes?

Consultation by a Heart Team (HT) is a class I recommendation by the American College of Cardiology, American Heart Association, and the European Society of Cardiology for the management of patients with complex cardiac disease. Despite the class I recommendation, there is a paucity of data to support the role of an HT with only level C quality of evidence. This study was performed to follow patients who were referred for HT consultation and long-term outcomes in relation to whether the recommendation of the HT was followed or not. We performed a prospective analysis of our cohort of patients who underwent consultation by the HT. A total of 342 cases have been followed. Patient characteristics, referring physicians' favored treatment, and key outcomes were followed. A total of 336 patients were reviewed; 70.4% were male patients with a median age of 66.3 years and an average EuroSCORE II score of 7.2%. A total of 79.9% of the discussions resulted in a unanimous decision. The recommendations made by the HT differed from those documented by the referring physician in 54% of cases. In conclusion, recommendations made by the HT were followed in 269 cases (83.8%). There was a significant reduction in cardiac death (6.3% vs 15.3%, p = 0.042), composite cardiac outcome (23.4% vs 51.9%, p ≤0.001), and hospital admissions (10.4% vs 36.5%, p ≤0.001) when recommendations were followed. There was no statistical difference between the 2 groups when looking at noncardiac death, stroke, ST-segment elevation myocardial infarction, non-ST-segment elevation myocardial infarction, dialysis, or an emergency room visit.

The Critical Transfer From Paediatrics to Adult Care in Patients With Congenital Heart Disease: Predictors of Transfer and Retention of Care.

Background: Congenital heart disease is the most common congenital birth defect and presents with differing degrees of complexity. Patients require lifelong specialized care. The transfer from paediatric to adult care is a time of risk that may result in lapses or loss of care. A successful transfer from paediatric to adult care is integral for improved patient outcomes. Methods: In this retrospective study, we used the paediatric cardiology database and the electronic records at the adult congenital heart disease (ACHD) clinic to identify referrals and successful transfer between 2008 and 2017. Successful transfer was defined as a patient referred to the ACHD clinic who was seen in the clinic and has ongoing follow-up. We also sought to identify predictors of a successful transfer. Results: A total of 555 patients were referred to the ACHD clinic (2008-2017). Of all patients referred, 62% had a successful transfer and an ongoing specialist care. The remaining 38% either did not show for first appointments or missed 3 consecutive visits. Independent predictors of a successful transfer were the presence of moderate or complex ACHD, residing within the city limits, older age at the time of referral, and a more recent year of referral. Conclusions: Over one-third of patients did not achieve successful transfer, namely attendance at first clinic visit plus early retention in care. We were able to identify several variables that predict successful transfer. Further research is required to identify interventions that can be implemented to reduce lapses in patient care.

Contexte: La cardiopathie congénitale, qui est la malformation congénitale la plus courante, présente divers degrés de complexité. Les patients qui en sont atteints nécessitent des soins spécialisés tout au long de leur vie. La transition entre les soins pédiatriques et les soins pour adultes est un moment risqué qui peut occasionner un relâchement ou une interruption des soins. Le succès de ce transfert des soins pédiatriques aux soins pour adultes est essentiel à l'amélioration des résultats pour les patients. Méthodologie: Pour cette étude rétrospective, nous avons utilisé la base de données de cardiologie pédiatrique et les dossiers électroniques de la clinique de cardiopathie congénitale de l'adulte (CCA) pour relever les cas de réorientation et de transfert réussi survenus entre 2008 et 2017. On entendait par « transfert réussi ¼ le fait qu'un patient orienté vers la clinique de CCA ait été vu en consultation à la clinique et qu'il fasse l'objet d'un suivi. Nous avons aussi cherché à identifier les facteurs prédictifs d'un transfert réussi. Résultats: Au total, 555 patients ont été orientés à la clinique de CCA entre 2008 et 2017. Chez 62 % de tous ces patients orientés, le transfert a été réussi et les soins spécialisés ont été poursuivis. Les patients représentant les 38 % restants ne se sont pas présentés soit à leur premier rendez-vous, soit à trois visites subséquentes consécutives. Les facteurs prédictifs indépendants du transfert réussi étaient la présence d'une CCA modérée ou complexe, le fait de résider à l'intérieur des limites de la ville, un âge plus avancé au moment de la réorientation et le caractère plus récent de la réorientation. Conclusions: Chez plus du tiers des patients, le transfert n'a pas été réussi, c'est-à-dire que ces patients ne se sont pas présentés à leur première visite à la clinique et que leurs soins n'ont pas été poursuivis rapidement après le transfert. Nous avons pu cerner plusieurs variables qui prédisent les transferts réussis. D'autres recherches seront nécessaires pour trouver les interventions à mettre en œuvre pour réduire les interruptions dans les soins aux patients.

Delirium definition influences prediction of functional survival in patients one-year postcardiac surgery.

BACKGROUND: Delirium after cardiac surgery is associated with prolonged intensive care unit (ICU) and hospital length of stay and elevated rates of mortality. The Society of Thoracic Surgery National Database (STS-ND) includes delirium in routine data collection but restricts its definition to hyperactive symptoms. The objective is to determine whether the Confusion Assessment Method for ICU (CAM-ICU), which includes hypo- and hyperactive symptoms, is associated with improved prediction of poor 1-year functional survival following cardiac surgery. METHODS: Clinical and administrative databases were used to determine the influence of postoperative delirium on 1-year poor functional survival, defined as being institutionalized or deceased at 1 year. Patients experiencing postoperative delirium using the STS-ND definition (2007-2009) were compared with patients with delirium identified by the CAM-ICU (2010-2012). A propensity score match was undertaken, and multivariable Cox proportional hazards regression models were generated to determine risk of poor 1-year functional survival. RESULTS: There were 2756 and 2236 patients in the STS-ND and CAM-ICU cohorts, respectively. Propensity matching resulted in a cohort of 1835 patients (82.1% matched). The overall rate of delirium in the matched study population was 7.6% in the STS-ND cohort and 13.0% in the CAM-ICU cohort (P < .001). Delirium in the CAM-ICU cohort was independently associated with poor 1-year functional survival (hazard ratio, 2.58; 95% confidence interval, 1.20-5.54; P = .02); delirium in the STS-ND cohort was not associated with poor 1-year functional survival (hazard ratio, 0.92; 95% confidence interval, 0.49-1.71; P = .79). CONCLUSIONS: A systematic screening tool identifies postoperative delirium with improved prediction of poor 1-year functional survival following cardiac surgery.

Use of a mobile health application by adult non-congenital cardiac surgery patients: A feasibility study.

Mobile Health (mHealth) technologies are becoming integral to our healthcare system. This study evaluated the feasibility (compliance, usability and user satisfaction) of a mHealth application (app) for delivering Enhanced Recovery Protocols (ERPs) information to Cardiac Surgery (CS) patients peri-operatively. This single centre, prospective cohort study involved patients undergoing CS. Patients received a mHealth app developed for the study at consent and for 6-8 weeks post-surgery. Patients completed system usability, patient satisfaction and quality of life surveys pre- and post-surgery. A total of 65 patients participated in the study (mean age of 64 years). The app achieved an overall utilization rate of 75% (68% vs 81% for <65 and ≥65 years respectively). Pre-surgery, the majority of patients found the app easy to use (94%), user-friendly (89%), and felt confident using the app (92%). The majority also found the app's educational information useful (90%) and easy to find (88%). 75% of patients reported that they would like to use the app frequently. This percentage decreased to 57% in the post-discharge survey. A lower percentage of patients ≥65 years indicated their preference for the app over printed information (51% vs 87%) and their recommendation for the app (84% vs 100% for >65 and <65 years respectively) in the post-surgery survey. MHealth technology is feasible for peri-operative CS patient education, including older adult patients. The majority of patients were satisfied with the app and would recommend using it over the use of printed materials.

Characterizing Physician-Staffing Models in the Care of Postoperative Cardiac Surgical Patients in Canada.

BACKGROUND: Current intensive care unit physician-staffing (IPS) models for postoperative cardiac surgery have not been previously investigated in Canada. The purpose of this study was to determine current IPS models at 2 time points and describe the evolution of Canadian cardiac surgery IPS models. METHODS: A survey of 32 Canadian cardiovascular intensive care units (CVICUs) was undertaken in 2012 and 2017 to determine IPS models of care during "daytime" and "after-hours" in each unit. Data were collected regarding surgical volume, base specialties, and style of IPS management ("open"; "semi-open"; "closed"). In addition, we collected the overnight experience level of the bedside healthcare provider for in-house intensive care units. RESULTS: Survey responses were received from 27 of 32 CVICUs (87%). As of 2017, the style of 1 (4%) was open, 7 (26%) were semi-open, and 19 (70%) were closed in their unit IPS strategy. Base specialties of CVICU physicians varied. A medical doctor provided after-hours coverage in 81% of CVICUs. Senior residents (37%) or critical care certified attending staff (25%) typically provided after-hours coverage for in-house CVICUs. Linked Canadian Institute for Health Information data did not indicate a difference among CVICU models in mortality or rehospitalization for coronary artery bypass graft or valve procedures. CONCLUSIONS: Considerable heterogeneity is demonstrated in CVICU staffing patterns. No consensus was identified regarding the appropriate level of training for "after-hours" coverage. In-house overnight physician staffing in CVICUs varies widely. Finally, semi-open and closed style models did not demonstrate differences compared to Canadian Institute for Health Information data. Variability among CVICUs does exist; however, benefits of one model over another have not been identified.

INTRODUCTION: Les modèles actuels de dotation en médecins aux soins intensifs (DMSI) postopératoires de chirurgie cardiaque n'ont pas fait l'objet d'études antérieures au Canada. L'objectif de la présente étude était de déterminer les modèles actuels de DMSI à deux points temporels et de décrire l'évolution des modèles de DMSI de chirurgie cardiaque au Canada. MÉTHODES: Nous avons entrepris une enquête auprès de 32 unités de soins intensifs cardiovasculaires du Canada (USICC) en 2012 et en 2017 pour déterminer les modèles de soins DMSI « pendant la journée ¼ et « après les heures normales ¼ dans chaque unité. Nous avons collecté les données relatives au volume d'interventions chi- rurgicales, aux spécialités de base et au style de gestion de la DMSI (« ouvert ¼, « semi-ouvert ¼, « fermé ¼). De plus, nous avons collecté les données sur le niveau d'expérience de nuit des prestataires de soins au chevet des patients des unités intégrées de soins intensifs. RÉSULTATS: Nous avons reçu les réponses à l'enquête de 27 des 32 USICC (87 %). Depuis 2017, le style de 1 (4 %) USICC était ouvert, de 7 (26 %) était semi-ouvert et de 19 (70 %) était fermé dans leur stra- tégie de DMSI à l'unité. Les spécialités de base des médecins de l'USICC variaient. Un docteur en médecine offrait ses services après les heures normales dans 81 % des USICC. Les résidents chevronnés (37 %) ou les médecins titulaires agréés en soins aux patients en phase critique (25 %) offraient habituellement leurs services après les heures normales aux USICC intégrées. Les données liées de l'Institut canadien d'information sur la santé n'indiquaient pas de différence entre les modèles des USICC en ce qui a trait à la mortalité ou à la réhospitalisation en raison de pontages aortocoronariens ou d'interventions valvulaires. CONCLUSIONS: Les modèles de dotation en personnel aux USICC démontrent une importante hétérogénéité. Aucun consensus n'a été établi quant au niveau approprié de formation pour les services offerts « après les heures normales ¼. Le personnel médical de nuit à l'interne des USICC varie grandement. Finalement, les modèles de styles semi-ouverts et fermés ne démontraient pas de différence par rapport aux données de l'Institut canadien d'information sur la santé. Une variabilité existe entre les USICC. Toutefois, les avantages d'un modèle par rapport à un autre n'ont pas été définis.

A Quality Improvement Initiative to Reduce Postoperative Delirium among Cardiac Surgery Patients.

Patients following cardiac surgery commonly experience post-operative delirium (POD) during their postoperative hospital stay. A multifaceted, specialty wide, quality improvement (QI) project was undertaken for patients experiencing POD. The goal was to develop a reduction in POD care bundle (rPOD-a structured patient care program) that encompasses efficient preoperative risk factor identification and a postoperative patient-care process to ensure early POD identification and treatment. The following steps were taken to implement the rPOD care bundle including: (a) Developing a quality driven, evidence-based guideline for the perioperative cardiac surgery health care team, (b) identifying and addressing local barriers to implementation, (c) selecting performance measures to assess intervention adherence and patient outcomes, and (d) ensuring that all patients receive the interventions through staff engagement and education, and regular project evaluation. Trends of process measures and quality improvement measures were examined. An increasing trend in the rate of postoperative delirium screening during implementation of rPOD intervention was demonstrated. This quality improvement study provides a bases for future postoperative delirium reduction interventions.

Population and Resource Utilization Among Patients With Adult Congenital Heart Disease: A Snapshot View of a Moderate-Size Canadian Regional Centre.

BACKGROUND: Health care resource utilization for patients with adult congenital heart disease (ACHD) has not been well characterized outside of large Canadian specialized regional centres. We sought to describe the ACHD population and resource utilization patterns seen in a medium regional Canadian centre providing specialized ACHD care. METHODS: A cross-sectional retrospective study was done from a sample of patients seen in 2018 at the ACHD clinic in Manitoba, Canada. Demographic data were collected along with cardiac anatomy and repair type. Health care resource utilization, clinic visits, hospital admissions, unexpected hospital presentations, and cardiac interventions were measured over a 5-year period. RESULTS: A random sample of 262 patients was selected from our specialized ACHD clinic. Mean age was 33.5 (±13.7) years; 48% of the population was female, and >50% resided within the major city limits. A total of 21% of the population had simple anatomy, 44% had moderate anatomy, and 35% had complex anatomy. The most commonly used imaging modality was echocardiography, followed by cardiac magnetic resonance imaging, with more frequent imaging done in patients with complex anatomy. Unexpected hospital encounters occurred at a rate of 16 per 100 person-years. Total inpatient hospital days occurred at a rate of 33 per 100 person-years, and visits to the congenital clinic occurred at a rate of 90 per 100 person-years. CONCLUSIONS: Health care resource utilization appears to be highest in older adults and those with more complex ACHD anatomy. As the overall cohort of adults with ACHD continues to age, resource needs are likely to increase.

CONTEXTE: L'utilisation des ressources de santé à l'extérieur des grands centres spécialisés régionaux au Canada n'a pas été bien caractérisée pour les patients atteints de cardiopathie congénitale de l'adulte (CCA). Nous avons cherché à décrire la population atteinte de CCA et les schémas d'utilisation des ressources observés dans un centre régional canadien de taille moyenne fournissant des soins spécialisés en CCA. MÉTHODOLOGIE: Une étude transversale rétrospective a été réalisée à partir d'un échantillon de patients rencontrés en 2018 dans une clinique spécialisée en CCA du Manitoba, au Canada. Des données démographiques ont été recueillies de même que des données sur l'anatomie cardiaque et le type de réparation. L'utilisation des ressources de soins de santé, les visites à la clinique, les admissions à l'hôpital, les consultions hospitalières imprévues et les interventions cardiaques ont été mesurées sur une période de cinq ans. RÉSULTATS: Un échantillon aléatoire de 262 patients a été sélectionné dans notre clinique spécialisée en CCA. L'âge moyen des patients était de 33,5 (±13,7) ans; 48 % de la population était de sexe féminin et plus de 50 % résidait dans les limites d'une grande ville. Au total, 21 % de la population présentait une anatomie cardiaque simple, 44 % une anatomie modérément complexe et 35 % une anatomie complexe. La technique d'imagerie la plus utilisée était l'échocardiographie, suivie de l'imagerie par résonance magnétique cardiaque, l'imagerie étant plus fréquente chez les patients présentant une anatomie cardiaque complexe. Le taux de consultations hospitalières imprévues était de 16 pour 100 années-patient. Le nombre total de jours d'hospitalisation était de 33 pour 100 années-patient, et le nombre de visites à la clinique spécialisée en CCA était de 90 pour 100 années-patient. CONCLUSIONS: L'utilisation des ressources de soins de santé semble être plus élevée chez les adultes plus âgés et chez ceux qui présentent une anatomie plus complexe liée à la CCA. Puisque l'ensemble de la cohorte d'adultes atteints de CCA continue de vieillir, les besoins en ressources sont susceptibles d'augmenter.

The Epidemiology of Endocarditis in Manitoba: A Retrospective Study.

BACKGROUND: Recently, anecdotal evidence suggested an increase in infective endocarditis (IE) in Manitoba driven by an increasing proportion of patients with intravenous drug use (IVDU)-associated endocarditis. This study aimed to characterize the observed changing incidence and epidemiology of IE. METHODS: This retrospective study evaluated consecutive patients >18 years old with an International Classification of Disease-10 diagnosis of IE who presented to a tertiary referral center in Winnipeg, Manitoba between January 1, 2004 and December 31, 2018. Data were obtained by individual review of paper and electronic medical records and entered into the Research Electronic Data Capture database. Mortality and hospital readmission data were acquired by linking Research Electronic Data Capture data to the Manitoba Centre for Health Policy, which prospectively maintains a comprehensive population-based health database. RESULTS: A total of 612 cases of IE were identified. The incidence of IE increased from 2.03 per 100,000 in 2004 to 5.16 per 100,000 in 2018, with IVDU-associated cases increasing from 0.11 to 2.87 per 100,000. Left heart vegetations were most common in the non-IVDU group, whereas right-sided vegetations dominated in the IVDU group. All-cause mortality did not differ between IVDU and non-IVDU IE, despite a significantly younger age in patients with IVDU. The IVDU group showed a higher rate of endocarditis recurrence. CONCLUSIONS: In this first study to examine the longitudinal incidence of IE in Manitoba, we showed that the incidence of IE has significantly increased over the last 15 years, with a contribution of IVDU-associated IE that has a high rate of mortality and disease recurrence.

INTRODUCTION: Des données anecdotiques récentes montraient une augmentation de l'endocardite infectieuse (EI) au Manitoba attribuable à la proportion accrue de patients atteints d'une endocardite associée à l'usage de drogues par voie intraveineuse (UDVI). La présente étude avait pour but de caractériser les changements observés dans l'incidence et l'épidémiologie de l'EI. MÉTHODES: Cette étude rétrospective a permis d'évaluer les patients consécutifs > 18 ans qui avaient un diagnostic d'EI conformément à la Classification internationale des maladies, 10e révision, et qui s'étaient présentés dans un centre d'aiguillage en soins tertiaires de Winnipeg, au Manitoba, entre le 1er janvier 2004 et le 31 décembre 2018. Nous avons obtenu les données par l'examen du dossier individuel et des dossiers médicaux électroniques de la base de données Research Electronic Data Capture. Nous avons obtenu les données sur la mortalité et les réadmissions à l'hôpital par la liaison des données de la Research Electronic Data Capture au Manitoba Centre for Health Policy, qui maintient de manière prospective une base de données exhaustive sur la santé de la population. RÉSULTATS: Nous avons trouvé un total de 612 cas d'EI. L'incidence de l'EI est passée de 2,03 par 100 000 en 2004 à 5,16 par 100 000 en 2018, et l'incidence des cas d'EI associée à l'UDVI, de 0,11 à 2,87 par 100 000. Les végétations du cœur gauche étaient plus fréquentes dans le groupe de patients atteints d'une EI non associée à l'UDVI, alors que les végétations du cœur droit dominaient dans le groupe de patients atteints d'une EI associée à l'UDVI. La mortalité toutes causes confondues ne différait pas entre les patients atteints d'une EI associée à l'UDVI ou non associée à l'UDVI, en dépit de l'âge significativement plus jeune des patients atteints d'une EI associée à l'UDVI. Le groupe de patients atteints d'une EI associée à l'UDVI montrait un taux plus élevé de récurrence de l'endocardite. CONCLUSIONS: Dans cette première étude, qui portait sur l'incidence longitudinale de l'EI au Manitoba, nous avons montré que l'incidence de l'EI avait considérablement augmenté au cours des 15 dernières années, puisque l'EI associée à l'UDVI a contribué à l'augmentation du taux de mortalité et de récurrence de la maladie.

Impact of spironolactone exposure on prostate cancer incidence amongst men with heart failure: A Pharmacoepidemiological study.

AIMS: Aldosterone has been found to influence cancer cell growth, cell cycle regulation and cell migration, including in prostate cancer cells. Spironolactone is an aldosterone antagonist used for managing chronic heart failure (HF) with known antiandrogenic effects. We examined the effect of spironolactone exposure amongst men with HF on the incidence of prostate cancer. METHODS: This retrospective cohort study utilized provincial clinical and administrative databases from the Manitoba Centre for Health Policy. Incident cases of prostate cancer were identified from the provincial cancer registry, and spironolactone exposure was quantified from pharmacare databases. A multivariable proportional hazards model was used to assess the time-dependent impact of spironolactone exposure on prostate cancer incidence. RESULTS: A total of 18 562 men with newly diagnosed HF from 2007 to 2015 with a median age of 72 years (interquartile range: 61-81) and a median follow-up from HF diagnosis to prostate cancer incidence of 2.7 years (interquartile range: 1.1-4.9) were included. A time-dependent multivariable analysis of spironolactone exposure following HF diagnosis found a reduced the risk of prostate cancer hazard ratio 0.55 (95% confidence interval 0.31-0.98, P = .043). CONCLUSION: Spironolactone exposure significantly reduced the incidence of prostate cancer amongst men with HF. These findings support the plausibility of aldosterone as a promoter of prostate cancer growth and development. Prospective clinical trials are warranted to further assess the role of spironolactone or other mineralocorticoid receptor antagonists as a means to prevent prostate cancer development or as an adjunctive measure to prostate cancer treatments.

Oxygen Management During Cardiopulmonary Bypass: A Single-Center, 8-Year Retrospective Cohort Study.

OBJECTIVE: To characterize the institutional oxygen management practices during cardiopulmonary bypass (CPB) in patients undergoing cardiac surgery, including any potential changes during an 8-year study period. DESIGN: A retrospective cohort study. SETTING: A tertiary care cardiac surgical program. PARTICIPANTS: Patients who underwent cardiac surgery involving CPB, with or without hypothermic circulatory arrest (HCA), between January 1, 2010, and December 31, 2017. MEASUREMENTS AND MAIN RESULTS: In addition to baseline patient characteristics, the authors recorded the partial pressures of arterial oxygen (Pao2), fraction of inspired oxygen, and mixed venous oxygen saturation during CPB of 696 randomly selected patients during an 8-year study period. The overall mean Pao2 was 255 ± 48 mmHg, without any significant change during the 8-year study period (p = 0.30). The mean Pao2 of HCA patients was significantly higher than in patients without HCA (327 ± 93 mmHg v 252 ± 45 mmHg, respectively; p < 0.001). CONCLUSIONS: The current approach to oxygen management during CPB at the authors' institution is within the range of hyperoxemic levels, and these practices have not changed over time. The impact of these practices on patients' outcomes is not fully understood, and additional studies are needed to establish firm evidence to guide optimal oxygen management practice during CPB.

A Province-Wide Analysis of the Epidemiology of Thoracic Aortic Disease: Incidence Is Increasing in a Sex-Specific Way.

BACKGROUND: The contemporary incidence and prevalence of thoracic aortic aneurysm and dissection (TAAD) remains understudied. Epidemiological research on TAAD has been limited by incomplete case identification within administrative data sources. The objectives of this study were to develop a case identification method and determine the incidence and prevalence of TAAD, based on data from Manitoba, Canada. METHODS: Hospital records and medical claims housed at the Manitoba Centre for Health Policy, and data from the Manitoba Thoracic Aortic Diseases Clinic were used to develop a case definition and identify patients with TAAD in Manitoba, Canada. The age-standardized incidence and prevalence of thoracic aortic disease was determined and stratified by sex from 1998 to 2016. RESULTS: We identified 4264 patients with TAAD, of whom 63% were male. The age standardized incidence was 2 times higher in men, peaking at 42 cases per 100,000 in 2013. Although the overall incidence was lower in female patients, the number of incident cases increased 68% compared with 25% in male patients. In hospitalized patients, the incidence and prevalence of aneurysms increased over time, whereas the incidence of dissection and rupture has remained stable. CONCLUSIONS: The use of a novel case identification method provided a more complete description of the epidemiology of TAAD. The incidence and prevalence of TAAD is rising, more so in female patients over time. These data support increased resource allocation to thoracic aortic diseases clinics to ensure appropriate monitoring, treatment, and follow-up for the growing number patients with thoracic aortic disease.

Short- and Long-term Outcomes of Medically Treated Isolated Left-Sided Endocarditis: A Retrospective Study With 5-Year Longitudinal Follow-up.

BACKGROUND: A retrospective study of medically treated isolated left-sided infective endocarditis (LSIE) patients identifying predictors of outcomes with nonoperative management was undertaken. METHODS: Medical records of 135 Manitoban medically managed LSIE patients from January 2004 to December 2016 were reviewed. Five-year survival for 135 patients and hospitalization data till March 2016 for 65 patients were collected from the Manitoba Centre for Health Policy. RESULTS: In-hospital mortality was 44%. Patients with surgical indications were more likely to die in-hospital than those without (53% vs 24%; P = 0.002). Survival at 1 and 5 years was 43% and 23%, respectively. All-cause readmission at 1 and 5 years was 64% and 84%, respectively. At 1 and 5 years, readmission from major adverse events (heart failure, stroke, endocarditis) was 25% and 47%, and from recurrent endocarditis was 17% and 26%, respectively. Severe valvular regurgitation was a risk factor for in-hospital mortality (odds ratio, 3.52; P = 0.022), poor long-term survival (hazard ratio [HR], 2.57; P < 0.001), and recurrent endocarditis (HR, 5.93; P < 0.001). Prosthetic valve endocarditis was a risk factor for poor long-term survival (HR, 2.11; P = 0.002). Streptococcus viridans group was associated with better rates of in-hospital mortality (odds ratio, 0.28; P = 0.018) and long-term survival (HR, 0.34; P < 0.001). CONCLUSIONS: Nonoperative management of LSIE carries a poor prognosis but may have a role in select cases. Surgical management remains the mainstay for patients with clear surgical indications, including severe regurgitation and prosthetic valve endocarditis. Further prospective analyses are required to better delineate appropriate patient selection for nonsurgical management.